The new Regulations in effect make vaccination against Covid-19 mandatory for all those undertaking work activities in regulated care homes, except in very limited circumstances.   

The Regulations bar from entry to regulated care homes all those who have not received a complete course of vaccination against Covid-19 unless they can prove that for clinical reasons they should not be vaccinated or they are: under 18; a resident, or friend or relative of a resident; providing emergency services or assistance, or urgent maintenance of the premises; or visiting a resident who is dying or who has suffered bereavement. The new Regulations achieve this by laying a new responsibility on the "responsible person" at a registered care home – namely, to ensure that those falling outside these exceptions are denied entry.

The new Regulations come into force on 11 November 2021, 16 weeks after being made. They require the Secretary of State to review them and publish the resulting report within one year of their coming into force and each year thereafter, but they are not sunsetted. The Explanatory Memorandum (EM) accompanying the Regulation says that the review report must be laid before Parliament, but there is no explicit requirement to this effect in the Regulations.

The new Regulations are the first explicit provision in English law making a person’s Covid-19 vaccination status a characteristic which affects eligibility to carry out work activities. As such, they are a standout example of delegated legislation being used to enact significant policy change.  

The new Regulations were made using powers in Sections 20 and 161 of the Health and Social Care Act 2008 as amended by the Health and Social Care (Quality and Safety) Act 2015.

The 2008 Act was intended, in part, to address infection control in the health and care sector, including during a SARS-type pandemic; but there is little indication in the relevant debates that parliamentarians considered the possibility of the powers in the Bill being used to introduce mandatory vaccination of workers in the sector.

However, the relevant powers are sweeping: since the 2015 amendments (passed in the wake of the mid-Staffordshire hospital scandal), the Secretary of State is *required* to make regulations to ensure that regulated health and care activities “cause no avoidable harm” to those receiving services. Even under the original 2008 Act, the Secretary of State is empowered to make regulations imposing “in relation to regulated activities any requirements which [s/he] thinks fit” for the purposes of the relevant part of the Act. Parliament’s Joint Committee on Statutory Instruments (JCSI), which scrutinises the technical aspects of delegated legislation, raised no concerns as to whether the Regulations were within the scope of the government’s powers in this case.

However, where broad powers in an Act mean that Ministers *could* enact a measure by delegated legislation, it does not necessarily mean that they *should*.

Given the ethical and practical significance of the policy change they enact, the care home Covid vaccination Regulations once again raise the question of whether delegated legislation is being used for its intended purpose.    

When Ministers have powers to enact a measure by delegated legislation, they may nevertheless legislate for it by primary legislation instead, in a Bill.

Often, Ministers seek to justify the use of delegated legislation by claiming a need for speed. In the case of the new care home Regulations, the government wished to secure compliance with the new vaccination requirements as early as possible before next winter; it reckoned that this requires 16 weeks; and it seems to have wanted to have the measure enacted in law before starting this countdown. Indeed, it became evident during the parliamentary proceedings on the new Regulations that the government wanted to legislate – rather than continue to rely only on existing methods – as a way of driving what it called the remaining "hard yards" of vaccine take-up among care home staff. This all meant that the government wanted to secure parliamentary approval for the new legislation before the summer parliamentary recess.

However, the new Regulations still took a calendar month from being laid before Parliament in draft on 22 June to being made (signed) into law by the Minister. Since the 2019 General Election, seven government Bills have passed through Parliament in less time (not counting a further nine finance-related Bills that also did so but may be subject to special procedures). The new Regulations took this length of time to become law partly because, under the 2008 Act, they were subject to the 'draft affirmative' procedure – that is, they may not be made into law unless and until they have received parliamentary approval. Among the regular parliamentary scrutiny procedures for delegated legislation, the 'draft affirmative' procedure potentially takes the longest in terms of sitting time before an SI can be made law: the guidance is to allow six sitting weeks.

The decision to use delegated legislation – rather than a Bill – to enact a measure has consequences for parliamentary scrutiny. Most obviously:

• Such delegated legislation as is debated at all – which includes measures subject to the 'draft affirmative' procedure, like the care home Regulations – is debated for less time (and not always in the Chamber, in either House).

• Delegated legislation cannot be amended. Parliamentarians are therefore left with a 'take it or leave it' decision about the legislation.

In addition to disquiet about the vaccination policy itself, parliamentarians in both Houses expressed unhappiness about the scrutiny process for the new care home Regulations.

Much of this unhappiness focused on shortcomings in the government’s provision of information about the SI. In its first report on the draft Regulations, published on 8 July, the House of Lords Secondary Legislation Scrutiny Committee (SLSC) raised three criticisms on this front:

1. The poor quality of the Explanatory Memorandum (EM). The SLSC suggested that the EM accompanying the draft Regulations failed to fully justify the proposed policy, including the decision to legislate at all; “lack[ed] all practical detail” about how the policy was to be implemented; gave an unclear presentation of statistics on vaccination take-up in care homes; and provided inadequate analysis of the responses to the public consultation which had been held in connection with the policy, including with respect to its human rights implications.

2. Practical detail being left to operational guidance which was promised only for the end of July, when both Houses would be in recess, and *after* they were being asked to approve the Regulations. (In the end, the guidance was published on 4 August.) In the SLSC’s view, this disjunction between the law and the guidance raised the prospect of another blurring of roles between the two, a running concern of parliamentary scrutiny committees and external observers during the Covid-19 pandemic.

3. The lack of an impact assessment. As confirmed by the government’s Regulatory Policy Committee, the new Regulations are covered by the statutory requirement for an impact assessment which is imposed by Part 2 of the Small Business, Enterprise and Employment Act 2015. Again, missing or late impact assessments for SIs have been a longstanding parliamentary complaint, heightened during the pandemic.

In the absence of the operational guidance and the impact assessment, in its first (8 July) report on the draft Regulations the SLSC declared that their “effective parliamentary scrutiny is impossible". The Committee recommended that the House of Lords’ debate on the draft SI should be deferred until the two documents were made available, and it announced that it was in any case seeking oral evidence on the Regulations from a Minister.

In the case of the care home vaccination Regulations, the government may well have faced a genuine tension between waiting for a full impact assessment to be ready for publication on the one hand, and pressing ahead without one on the other, given the need for parliamentary approval before enacting the legislation, the approach of the summer recess, and the timetable for vaccination. However, the substance of the work involved in the impact assessment should have been completed *before* the decision was taken to proceed with the policy. There were also ways of mitigating the problems created by the absence of the impact assessment – most obviously, by sunsetting the Regulations. Asking Parliament to approve a non-sunsetted policy change of this gravity without a published impact assessment represents, as the SLSC stated, "particularly poor practice".

The government aggravated its treatment of Parliament by giving incorrect and inconsistent information about the status of the impact assessment:

• The Explanatory Note at the end of the draft Regulations (laid on 22 June) stated: “A full impact assessment … is available from the Department of Health and Social Care”.

• The Explanatory Memorandum accompanying the draft Regulations stated: “A full impact assessment has been prepared and will be submitted [to Parliament]”.

• The Minister, Helen Whately MP, told the House of Commons' debate on the draft Regulations, in the Chamber on 13 July: “The impact assessment is being worked on”.

As of 9 August, the impact assessment has yet to appear. (The versions of the Explanatory Note and Explanatory Memorandum which accompanied the ‘made’ version of the Regulations on 22 July stated that no impact assesssment had been published.)

Post-Covid reform of the delegated legislation system should clarify the circumstances in which a Statutory Instrument normally requiring an impact assessment may proceed without one. There also needs to be a toughened approach towards any failure to produce an impact assessment in line with statutory and parliamentary expectations.

The government’s handling of the impact assessment drew some of the sharpest criticism in what proved to be a heated House of Commons debate. Deputy Speaker Nigel Evans MP, in the Chair, called the situation “totally unsatisfactory”.

Some MPs raised a further issue in connection with the information available about the draft Regulations, namely the failure of their title to identify their central subject. Again, scrutiny committees have previously raised the issue of SIs' titles; and the government’s own guidance states that an SI’s “title should give an accurate indication of the nature of the SI, and distinguish it from all others”. However, some MPs suggested that the anodyne title of the new Regulations, lacking any reference to care homes or vaccination, might leave some of their colleagues unaware of the nature of the measure before the House .

MPs with concerns, whether about the vaccination policy or the missing impact assessment, found their ability to do much about these severely constrained by the procedures of the House of Commons:

Echoing the SLSC’s call in the House of Lords, Sir Graham Brady MP was among those who called for the House’s decision on the Regulations to be deferred, pending the appearance of the impact assessment. However, in the House of Commons, the government determines when government business comes before the House.

MPs who wished to defer the House’s decision, or who had other concerns about the draft Regulations, could not point in support of their position to any report from a Commons committee which had scrutinised the substance of the legislation. The House of Commons has no dedicated committee for scrutiny of SIs’ policy merits.

MPs variously called the maximum 90-minute length of the debate on the draft Regulations "a disgrace", "an insult to care workers" and "frankly offensive". However, the 90-minute maximum length for a debate on an affirmative SI is prescribed by Standing Order (SO No. 16). Any move to set the Standing Order aside would be heavily circumscribed by the arrangements for the timetabling of Commons business. In the event, while many House of Commons debates on affirmative SIs last for less than 20 minutes, MPs debated the care home vaccination Regulations for the full 90.

Under the circumstances, the only option open to MPs who were sufficiently unhappy about the situation was to oppose the approval motion for the draft Regulations on 13 July – as 33 Conservative  MPs did, to no avail. The approval motion was agreed by 319 to 246.

Compared to the process in the House of Commons, the fate of the care home vaccination Regulations in the House of Lords shows how the procedures there enable more effective scrutiny of SIs – in the case of these Regulations, in three respects:

1. The House of Lords is self-governing. In contrast to government control in the Commons, the House of Lords determines its own business to a much greater extent. In the case of the care home vaccination Regulations, after the SLSC recommended that the House’s debate and decision be delayed pending the government’s provision of further information, the Lords debated the Regulations a week after the Commons. (This rendered pointless the government’s haste in the Commons, given that the Minister could make the draft Regulations into law only once they had been approved by both Houses – although no MP referred to this point in the Commons debate.) In the time before the later Lords debate was held, the SLSC took evidence from a Minister (on the same afternoon as the Commons was debating the Regulations) and produced a further report.

2. The House of Lords has a dedicated committee to scrutinise SIs’ policy merits. As a result of the work of the SLSC, the House of Lords had a basis for the decision about the timing of the House’s debate and decision on the draft Regulations. It also had greater information available to it when it did come to hold its debate. By the time of the Lords debate, the SLSC had: produced two reports, both including extensive correspondence with the department; published several external submissions;  and taken evidence from a Minister. Moreover, in the course of his evidence session, the Minister – Nadhim Zahawi MP – committed to publishing, ahead of the Lords debate, not the impact assessment but at least a ‘Statement of Impact’ about the Regulations. This duly appeared, albeit only the day before the debate, and contained further information.

3. House of Lords approval motions for affirmative SIs are amendable. In the House of Lords, unlike the House of Commons, Members may table amendments to a motion that an affirmative SI be approved. Such an amendment could withhold the House’s approval from an SI; but Peers are much more likely to amend an approval motion so as to express ‘regret’ about some aspect of the SI, while still approving it. In the case of the care home vaccination Regulations, the Lords agreed an amendment moved by Labour’s Baroness Wheeler regretting the absence of the impact assessment  and the reliance on then-still-unpublished guidance. While such ‘non-fatal’ expressions have no legal effect, they at least allow Members to put the substance of their unhappiness about an SI on the record in a decision of the House. Compared to the situation in the Commons, the possibility of triggering a debate on – and perhaps securing approval of – an amendment also provides greater incentive for Members of the Lords to engage with SIs.

While the House of Lords' more effective scrutiny arrangements generated additional material about the new care home Regulations, the government has still been able to enact a significant, non-sunsetted, policy change in delegated legislation without Parliament having had the information or scrutiny time on it that many Members felt they needed.

The urgency and uncertainty involved in tackling the pandemic have been hard to accommodate within normal policy and legislative processes – but the pandemic response is now well over a year old, and the government's behaviour over the care home Regulations suggests that it has not learned lessons about how best to take Parliament with it in these circumstances.

In any case, many of the frustrations parliamentarians encountered during proceedings on the care home Regulations were not new. This underlines the fact that factors much older than the pandemic were also at work. As well as addressing how best to legislate during an emergency, post-Covid reform of delegated legislation must achieve change in these longstanding shortcomings in practices and procedures if the quality of law-making and its scrutiny is to improve.

The research for this post was supported by the Legal Education Foundation as part of the Hansard Society’s Review of Delegated Legislation

Fowler, B., The care home Covid vaccination Regulations: a case study in problems with the delegated legislation system, (London: Hansard Society), 9 August 2021